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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04088487
Other study ID # WP/2018/A/10
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 14, 2020
Est. completion date May 8, 2020

Study information

Verified date November 2020
Source University of Social Sciences and Humanities, Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness.


Description:

The number of migrants worldwide is growing rapidly over the past years. Migration often requires creating a whole new social network. There is something that can help migrants to do it-their beliefs. Social self-efficacy is confidence in ability to engage in social interactional tasks necessary to initiate and maintain interpersonal relationships. These beliefs are positively related to social adjustment and negatively related to acculturative stress, depression, and loneliness. Therefore, social self-efficacy may be potentially beneficial for the psychological adjustment of migrants helping them establish new connections in the social environment. Based on this observation the investigators have created New in Town, an internet intervention. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states. The effectiveness of New in Town intervention will be tested in a two-arm randomized controlled trial with waitlist control group. Primary outcome is social self-efficacy, and secondary outcomes include loneliness, perceived social support, and satisfaction with life. Other measure of interest is system usability. Participants will be assessed at pre-test (T1), 3-week post-tests (T2), as well as 8-week follow-up (T3). The investigators aim to analyze the effect size of the intervention and between-groups comparisons at post-test and follow-up. This study will provide insights into the effectiveness of an internet intervention in increasing social self-efficacy, perceived social support and satisfaction with life, and reducing loneliness.


Recruitment information / eligibility

Status Terminated
Enrollment 178
Est. completion date May 8, 2020
Est. primary completion date April 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age of at least 18 years - having changed the place of residence in the last 6 months Exclusion Criteria: - no access to a internet

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
New in Town-Interner Intervention for Migrants
New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states (Bandura, 1997).

Locations

Country Name City State
Poland SWPS University of Social Sciences and Humanities Warsaw Warszawa

Sponsors (1)

Lead Sponsor Collaborator
University of Social Sciences and Humanities, Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (10)

Bandura, A. (1997). Self-efficacy: The exercise of control. Macmillan.

Connolly, J. (1989). Social self-efficacy in adolescence: Relations with self-concept, social adjustment, and mental health. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 21(3), 258.

Constantine MG, Okazaki S, Utsey SO. Self-concealment, social self-efficacy, acculturative stress, and depression in African, Asian, and Latin American international college students. Am J Orthopsychiatry. 2004 Jul;74(3):230-241. doi: 10.1037/0002-9432.74.3.230. — View Citation

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. — View Citation

Gierveld, J. D. J., & Van Tilburg, T. (1999). Manual of the loneliness scale. Amsterdam: Department of Social Research Methodology.

Luszczynska, A., Mazurkiewicz, M., Kowalska, M., & Schwarzer, R. (2006). Berlinskie skale wsparcia spolecznego (BSSS): Wyniki wstepnych badan nad adaptacja skal i ich wlasnosnciami psychometrycznymi = Berlin social support scales (BSSS): Polish version of BSSS and preliminary results on its psychometric properties. Studia Psychologiczne, 44(3), 17-27.

Schrepp, M., Pérez Cota, M., Gonçalves, R., Hinderks, A., & Thomaschewski, J. (2017). Adaption of user experience questionnaires for different user groups. Universal Access in the Information Society, 16(3), 629-640.

Sherer, M., Maddux, J. E., Mercandante, B., Prentice-Dunn, S., Jacobs, B., & Rogers, R. W. (1982). The self-efficacy scale: Construction and validation. Psychological reports, 51(2), 663-671.

Smith, H. M., & Betz, N. E. (2000). Development and validation of a scale of perceived social self-efficacy. Journal of Career Assessment, 8(3), 283-301.

United Nations (2017). 2017 International Migration Report.

Outcome

Type Measure Description Time frame Safety issue
Other System usability An overall impression of the intervention will be assessed by The User Experience Questionnaire (UEQ). It is a self-reported measure that contains 6 subscales: attractiveness, perspicuity, efficiency, dependability, stimulation, novelty. Participants respond to 26 items using a 7-point scale (-3 = the most negative answer, 0 = neutral, +3 = the most positive answer). User experience will only be assessed at post-test among participants allocated to the experimental group. 3-week post-test (only experimental group)
Primary Change on Social Self-Efficacy Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy. Change from baseline on Social Self-Efficacy (3 weeks)
Primary Change on Social Self-Efficacy Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy. Change from baseline on Social Self-Efficacy (8 weeks)
Secondary Change on Loneliness To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness. Change from baseline on Loneliness (3 weeks)
Secondary Change on Loneliness To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness. Change from baseline on Loneliness (8 weeks)
Secondary Change on Social support To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support. Change from baseline on Social support (3 weeks)
Secondary Change on Social support To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support. Change from baseline on Social support (8 weeks)
Secondary Change on Satisfaction with life To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life. Change from baseline on Satisfaction with life (3 weeks)
Secondary Change on Satisfaction with life To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life. Change from baseline on Satisfaction with life (8 weeks)
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